Not so fast, Mr President: Trump's plan for lowering prescription drug prices hits a roadblock, as Canada bans bulk drug exports
A new rule that took effect Monday paves the way for President Donald Trump to fulfill his promise of letting states import certain prescription drugs from Canada — but our neighbor up north is saying ‘not so fast.’
On Saturday, the Canadian government issued new measures to prevent bulk exports to the US that could worsen drug shortages across the country. Canada sources 68% of its drugs internationally, according to a statement from Minister of Health Patty Hajdu. The country has repeatedly taken the stance that the US’ importation rule wouldn’t be effective in lowering prescription drug prices, as its own market is so small.
“The need for vigilance in maintaining the national drug supply continues,” Hajdu’s statement read.
Starting Saturday, certain drugs intended for the Canadian market are banned from distribution outside the country if the sale “would cause or worsen a drug shortage.” Companies also have to provide information to “assess existing or potential shortages” when requested, and within 24 hours if there’s a serious risk.
The rule is part of Trump’s last-ditch effort to lower prescription drug prices for Americans, something he’s repeatedly promised to do. The president signed an executive order back in July calling for the FDA to complete the “rulemaking process” to allow the importation of Canadian prescription drugs. And last week, he announced plans to implement something called the “most favored nations” rule, which would tie prices in the US to those in other developed countries and end certain rebates paid to middlemen.
That rule, opposed by pharma companies, would come into effect in January, Trump said. It would apply to 50 costly Medicare Part B medicines. The plan is to phase in the lowest price in other countries and “blend” it with the average sales price, then add a flat amount per dose for each applicable drug.
In the meantime, Trump said he’d allow states to purchase cheaper drugs from Canada. But it could be a while before cheaper drugs make their way across the border — if ever. In its final rule issued back in September, the FDA said states, territories, tribes, pharmacists and wholesalers would need to set up new programs and submit applications to import drugs, which would have to meet several specifications. That would include relabeling and testing the drugs for “authenticity and degradation,” according to the FDA. And the programs would have to demonstrate “significant cost reductions” to the consumer.
“If you put Canadian drugs on a dogsled and pointed it in the direction of Florida, the dogs would arrive long before any drugs through this regulatory proposal,” former HHS official Chris Meekins told the Washington Post back in December.
Under a law established in 2003, such importation is only allowed if certified by the HHS secretary — and Alex Azar is the first to formally do so.
“Our health care system is a symbol of our national identity and we are committed to defending it. The actions we are taking today will help protect Canadians’ access to the medication they rely on,” Hajdu said in a statement.